NCT04105608

Brief Summary

The aim of this trial was to assess glycemic control and incretin release in subjects affected by type-2 diabetes, a condition in which GLP-1 release is impaired. It is known that nutrition affects a variety of factors in overall quality of life in diabetes and we hypothesized incretin secretion may improve in acute. As little is known regarding oxyntomodulin secretion in relation to diet, we explored this gut-derived hormone behavior as well. Hence, the administration of two meals was carried out; these were equal in terms of calories but different for macronutrients composition. Appetite rating was assessed as well through a 100-mm horizontal Visual Analogue Scale, either at fasting and for 4 hours once the meal was completed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

1 month

First QC Date

September 23, 2019

Last Update Submit

September 25, 2019

Conditions

Type-2 Diabetes

Keywords

DiabetesGLP-1OxyntomodulinDietVisual Analogue Scale

Outcome Measures

Primary Outcomes (1)

  • Changes in serum GLP-1 concentration

    Changes in serum GLP-1 levels following the ingestion of the two meals

    0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)

Secondary Outcomes (3)

  • Changes in plasma oxyntomodulin concentration

    0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)

  • Serum glucose and insulin levels

    0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)

  • Hunger-satiety scores (millimeters)

    0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)

Study Arms (2)

HFV meal

EXPERIMENTAL

A vegetarian meal high in dietary carbohydrate and fiber

Dietary Supplement: High-fiber vegetarian meal

MED meal

ACTIVE COMPARATOR

A Mediterranean-like meal

Dietary Supplement: Mediterranean-like meal

Interventions

High-fiber vegetarian mealDIETARY_SUPPLEMENT

The intervention consisted in the administration of a high fiber vegetarian meal prepared by our research group staff.

HFV meal
Mediterranean-like mealDIETARY_SUPPLEMENT

The intervention consisted in the administration of a Mediterranean-like meal prepared by our research group staff.

Also known as: Control meal
MED meal

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details1:1
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type-2 diabetes history of at least 2 years, age above 18 years, body mass index (BMI) between 25 and 35 kg/m2, and drug naïve and/or with metformin treatment.

You may not qualify if:

  • clinically significant neurological, endocrinological, or other systemic diseases, as well as those with acute illness and chronic inflammatory or infective disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Bio-Medico University of Rome

Rome, 00128, Italy

Location

Related Publications (1)

  • Di Mauro A, Tuccinardi D, Watanabe M, Del Toro R, Monte L, Giorgino R, Rampa L, Rossini G, Kyanvash S, Soare A, Rosati M, Piccoli A, Napoli N, Fioriti E, Pozzilli P, Khazrai YM, Manfrini S. The Mediterranean diet increases glucagon-like peptide 1 and oxyntomodulin compared with a vegetarian diet in patients with type 2 diabetes: A randomized controlled cross-over trial. Diabetes Metab Res Rev. 2021 Sep;37(6):e3406. doi: 10.1002/dmrr.3406. Epub 2020 Sep 24.

    PMID: 32926502DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Registered Dietitian Nutritionist

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 26, 2019

Study Start

November 1, 2017

Primary Completion

December 1, 2017

Study Completion

February 28, 2018

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations

IT(1)